Recall Z-0296-2021 ยท FYA Gown, Surgical
THREAD COUNSEL INC DBA LAWS OF MOTION
LOM Disposable Surgical Gowns/Medical Gowns, Single-Use
| Date | Sep 17, 2020 |
| Status | Open, Classified |
| Reason | Medical gowns distributed to customers did not include appropriate labeling, and some gowns may not meet FDA's standards for surgical gowns. |
| Root cause | Nonconforming Material/Component |
| Action | On September 17, 2020, the firm sent an Urgent Medical Device Recall letter to New York State. The customer was informed of the product deficiencies. The customer was asked to take the following actions: 1. Immediately identify and quarantine all Affected Gowns at your site. As per the FDA Release, dated August 28, 2020, medical personnel should not use or further distribute LOMs gowns until the FDA completes its investigation (Attachment A). Therefore, do not distribute or use the Affected Gowns. 2. Complete the attached Return Recall Response Form to confirm the number of Affected Gowns r |
| Quantity | 2.4 million |
| Distribution | Distributed to accounts in New York |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.